FDA's Clinical Investigation Design Guidance Explained

CDRH hopes its guidance on design considerations for pivotal clinical investigations for medical devices will result in fewer requests for additional data and additional analyses, and perhaps even fewer new studies.

CDRH Division of Biostatistics director Greg Campbell explained that the guidance should help medical device manufacturers to choose hte appropriate design for their pivotal studies for submission to FDA. "This should result in better trial design and improve the quality of the data that may support in a better way the safety and effectiveness demonstration for a device,” he said.

Campbell said the center believes that better quality data will lead to timelier FDA approval or clearance of premarket submissions and will speed U.S. patient access to new medical devices. In particular, he said, the center hopes that there will be fewer requests for additional data and additional analyses, and perhaps even for new studies.

The guidance describes the three stages of medical device clinical studies, including the exploratory stage, the pivotal stage, and the postmarketing stage.